21 CFR Part 820 Subpart G – Production and Process Controls

Description:

In this course you will learn about how each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications.

Curriculum For This Course:

Introduction

Overview

2 mins 10 secs

ISO, ICH and the FDA

1 min 30 secs

Program organization

1 min 25 secs

Program objectives

1 min 50 secs

Definition of a medical device

2 mins 11 secs

Class I, II and III

1 mins 33 secs

Intended use

1 mins 10 secs

History of 21 CFR Part 820

21 CFR 820 Timeline

1 min 50 secs

1906 - The Jungle

1 min 45 secs

1937 - Massengil Company

2 min 10 secs

1957 - Thalidomide

1 min 58 secs

1971 - Dalcon Corporation

2 mins 33 secs

1990 - FDA device recall report

2 min 10 secs

A regulatory evolution

1 min 30 secs

Production and Process Controls – Subpart G

Course introduction

45 secs

Learning objectives

1 min 05 secs

Specification, alert limits and action limits – Sec 820.70(a)

1 min 42 secs

Product and process control – Sec 820.70(b)

1 min 28 secs

Document and product design changes

1 min 32 secs

Personnel controls – Sec 820.70(d)

58 secs

Environmental and contamination control – Sec 820.70(c)(e)

1 min 18 secs

Buildings and facilities – Sec 820.70(f)

1 min 39 secs

Equipment controls – Sec 820.70(g)

1 min 21 secs

Custom & off the shelf equipment

1 min 42 secs

Equipment validation process - FAT

1 min 44 secs

Equipment validation process - SAT

51 secs

Maintenance schedule

48 secs

Calibration program

1 min 09 secs

Logbooks

1 min 55 secs

Maintenance action plan

1 min 27 secs

Maintenance schedule cards

1 min 37 secs

Manufacturing material / Line clearance – Sec 820.70(h)

1 min 30 secs

Conclusion

Final Exam

Certification

shares

Author

Don Rackham
B.S. in Molecular Biology from SJSU

Results-oriented-quality professional with over twenty years of experience in the life sciences, clinical diagnostics and the pharmaceutical industry. Extensive technical expertise in cellular analysis techniques and methods, and experience in a GMP/GLP environment.

Description:

In this course you will learn about how each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications.

Curriculum For This Course:

Introduction

Overview

2 mins 10 secs

ISO, ICH and the FDA

1 min 30 secs

Program organization

1 min 25 secs

Program objectives

1 min 50 secs

Definition of a medical device

2 mins 11 secs

Class I, II and III

1 mins 33 secs

Intended use

1 mins 10 secs

History of 21 CFR Part 820

21 CFR 820 Timeline

1 min 50 secs

1906 - The Jungle

1 min 45 secs

1937 - Massengil Company

2 min 10 secs

1957 - Thalidomide

1 min 58 secs

1971 - Dalcon Corporation

2 mins 33 secs

1990 - FDA device recall report

2 min 10 secs

A regulatory evolution

1 min 30 secs

Production and Process Controls – Subpart G

Course introduction

45 secs

Learning objectives

1 min 05 secs

Specification, alert limits and action limits – Sec 820.70(a)

1 min 42 secs

Product and process control – Sec 820.70(b)

1 min 28 secs

Document and product design changes

1 min 32 secs

Personnel controls – Sec 820.70(d)

58 secs

Environmental and contamination control – Sec 820.70(c)(e)

1 min 18 secs

Buildings and facilities – Sec 820.70(f)

1 min 39 secs

Equipment controls – Sec 820.70(g)

1 min 21 secs

Custom & off the shelf equipment

1 min 42 secs

Equipment validation process - FAT

1 min 44 secs

Equipment validation process - SAT

51 secs

Maintenance schedule

48 secs

Calibration program

1 min 09 secs

Logbooks

1 min 55 secs

Maintenance action plan

1 min 27 secs

Maintenance schedule cards

1 min 37 secs

Manufacturing material / Line clearance – Sec 820.70(h)

1 min 30 secs

Conclusion

Final Exam

Certification

shares

Author

Don Rackham
B.S. in Molecular Biology from SJSU

Results-oriented-quality professional with over twenty years of experience in the life sciences, clinical diagnostics and the pharmaceutical industry. Extensive technical expertise in cellular analysis techniques and methods, and experience in a GMP/GLP environment.